Pharmacopeia is the code of a country to record the pharmaceutical product standards and specifications, generally compiled by the national pharmacopoeia commission, and approved and promulgated for implementation by the national pharmaceutical product administration, while the international pharmacopeia is compiled and corrected by a recognized international organization or relevant countries through consultation. The update cycle of pharmacopeia of each country differs, and characteristics thereof also differ. Pharmacopeia of each country is summarized and compared here in this article.
Chinese Pharmacopoeia (CP):
It is familiar to us.
Issuance history and latest edition
The Pharmacopoeia of the People's Republic of China (hereinafter referred to as the CP), compiled by the Chinese Pharmacopoeia Commission, is currently published and updated every five years, with the latest edition of the CP 2015 Edition and the 10th edition since new China was founded.
Characteristics of the CP
The CP 2015 Edition comprises four volumes and contains a total of 5,608 varieties; Volume I contains a total of 2,598 TCM varieties, including 440 new admissions, 517 new revisions, and 7 rejections; Volume II contains a total of 2,603 chemical drug varieties, including 492 new admissions, 415 new revisions, and 28 rejections; Volume III contains a total of 137 biological product varieties, including 13 new admissions, 105 new revisions, 1 new general requirement for biological products, 3 new general chapters of biological products, and 6 rejections; Volume IV contains a total of 317 general requirements (appendices), including 38 general requirements for preparations integrated and revised from Volume I, Volume II and Volume III, 278 testing method appendices, 18 new testing methods, and 15 guiding principles. 270 pharmaceutical excipient varieties are contained, including 137 new admissions, 97 new revisions, and 2 rejections (Table 1).
Table 1 Summary Table of New Admissions and New Revisions of CP 2015 Edition
Japanese Pharmacopoeia
Issuance history and latest edition
The Japanese Pharmacopoeia (JP) is compiled by the Society of Japanese pharmacopoeia, and promulgated for implementation by the Ministry of Health, Labour and Welfare. The JP is updated once every 5 years during which, the edition will be revised, and 2 supplements will be published. The latest edition is JP17 (including Supplement I). Each previous edition is as shown in the following table: https://www.pmda.go.jp/files/000210780.pdf
Table 2 Update Situation of JP
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